Lupin Pharmaceuticals, Inc. has been granted final approval by the USFDA for its Abbreviated New Drug Application for Cefdinir for Oral Suspension, 250 mg/5mL.
Lupin was the first company to receive FDA final approval for the capsule form on (May 19, 2006) and the lower strength suspension (on May 31, 2006) of Cefdinir.
Lupin's Cefdinir capsules and suspensions are the AB-rated generic equivalent of Abbott Laboratories' Omnicef® which had U.S. sales of approximately $787 million for the 12-month period ending December 31, 2006, according to IMS Health.
Cefdinir is indicated for the treatment of patients with mild to moderate infections caused by susceptible bacteria.
Commercail shipment of Cefdinir for Oral Suspension, 250 mg/5mL in the U.S. has already started.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited (Mumbai, Indai).
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